NCT07510438Recruiting
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease - A First-in-Human (FIH) Study
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment of coronary artery disease.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 30 Mar 2026
- Start date
- 8 May 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Amplitude Vascular Systems, Inc.
- Diseases
- Coronary artery disease
- NCT number
- NCT07510438
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 8 May 2026 to the primary completion date, Dec 2026
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject experienced an acute Myocardial Infarction (MI), either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days prior to index procedure.
- Subject has a previous stent in the target vessel implanted within last six months.
- Any previous stent within 10 mm of the target lesion.
Other illness
- Subject has New York Heart Association (NYHA) class III or IV heart failure.
- Target lesion has a myocardial bridge.
Lab values
- Subject has renal failure with serum creatinine \>2.5 mg/dL, or chronic dialysis.
Other
- Unprotected LMCA diameter stenosis \>30%.
- Target vessel is excessively tortuous, defined as the presence of 2 or more bends \>90 degrees or 3 or more bends \>75 degrees.
- Evidence of aneurysm in target vessel within 10 mm of the target lesion.
- Target lesion in ostial location (LAD, RCA, LCX, or RI, within 5 mm of ostium) or in an unprotected LMCA.
- Target lesion is a bifurcation with ostial diameter stenosis ≥30%.
Who the study is looking for
- ≥ 18 years of age
- Subjects with native coronary artery disease
- Left ventricular ejection fraction (LVEF) ≥ 35% within 6 months
- The target lesion must be a single de novo coronary lesion
- The target lesion stenosis of left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with Stenosis of ≥70% and \<100% or Stenosis ≥50% and \<70% with evidence of ischemia
- Lesion length must not exceed 44 mm
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincent's Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Monash Health, Victorian Heart Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| St Vincent's Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.